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Does the Increase in Spine Surgery Reflect an Increase in Disease?

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Does the Increase in Spine Surgery Reflect an Increase in Disease?. Sohail K. Mirza, MD MPH Professor, Department of Orthopedics and Joint Professor, Department of Neurological Surgery University of Washington. NASS Format. X. UW Tech Transfer (Synthes). X. X. X. X. X. X. X.

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slide1

Does the Increase in Spine Surgery Reflect an Increase in Disease?

Sohail K. Mirza, MD MPH

Professor, Department of Orthopedics and

Joint Professor, Department of Neurological Surgery

University of Washington

slide2

NASS Format

X

UW Tech Transfer (Synthes)

X

X

X

X

X

X

X

Depuy, Surgical Dynamics, Synthes

(to UW Dept. of Orthopedics)

X

X

X

X

X

Depuy, Synthes (to Dept of Orthop)

X

X

disclosure
Disclosure
  • I hold the University of Washington Surgical Dynamics Endowed Chair for Spine Outcomes Research (approx $90k in 2006).
  • I receive royalties for surgical drills licensed by Synthes Spine through UW Office of Technology Transfer (approx. $16k in 2006).
  • UW Department of Orthopedics receives spine fellowship support, research support, and endowments from Synthes Spine and Depuy Spine. I work with the spine fellows and am involved with two of the research projects supported by these funds.
  • I prepared all the slides.

Sohail K. Mirza, MD, MPH

Professor, Department of Orthopedics and Sports Medicine

and Department of Neurological Surgery, University of Washington

Harborview Medical Center, Box 359798

325 Ninth Avenue

Seattle, WA 98104

Email: [email protected] Tel: 206 731 3658 Fax: 206 731 3227

slide5

Back Pain

1,865,196 results on 5/17/2002

707,000,000 results on 6/ 5/2007

26,100,000 results on 1/15/2008

slide6

New Technologies

Resolution of pedicle screw litigation

New posterior fixation devices

New anterior fixation devices

Cages

Bone graft substitutes

Bone morphogenetic proteins

Minimally invasive spine surgery

Computer-assisted surgery

Artificial discs

slide7

New Clinical Knowledge: RCTs

  • Fusion results in better pain and function outcome in patients with spondylolisthesis.
  • Fusion with instrumentation results in a higher fusion rate.
  • Instrumentation is associated with a higher complication rate.
  • Artificial disc replacement may avoid complications of fusion.
slide8

Normal

Degeneration

biochemical changes
Biochemical Changes
  • Water content
  • Proteoglycan content
  • Chondroitin to sulfate ratio
  • Collagen network
collagen
Collagen

Repetitive Sequence (GLY – X – Y )

X: proline

Y: hydroxyproline

Triple helix

Tryptophan substitution?

ala kokko science 1999 jama 2001 spine 2002
Ala-KokkoScience 1999JAMA 2001 Spine 2002

Col9A2: Glutamine  Tryptophan

Disc disease 6/157 (vs. 0/174 controls)

COL9A3: Arginine  Tryptophan

Disc disease 12% (vs. 5% controls)

Trp allele  3X risk for disc disease

potential physiological basis for disc associated back pain
Potential Physiological Basis for Disc-associated Back Pain
  • Initiation of a chemotactic response
  • Vascular ingrowth
  • Increased sensory innervation
  • Endplate cartilage defects
  • Inflammation
slide19

Ratio of Back Surgery Rates

Deyo, Mirza CORR 2006

slide20

Variation in Lumbar Fusion Rates

Per 1000 Medicare

Enrollees 2002-2003

Weinstein, Lurie et al Spine 2006

slide22

Variation in Lumbar Fusion Rates

Rate Per 1000 Medicare Enrollees

Weinstein, Lurie et al Spine 2006

slide23

Variation in Lumbar Surgery Rates

LaminectomyFusion

Variation in

Regional Rates8X20X

Weinstein, Lurie et al Spine 2006

causes of variation
Causes of Variation
  • Lack of scientific evidence
  • Financial Incentives and Disincentives
  • Clinical Training and Professional Opinion
  • New technology

Weinstein, Lurie et al Spine 2006

slide26

Procedure Comparisons (2001)

Deyo, Nachemson, Mirza NEJM 2004

slide27

Annual Number of Operations in U.S.

Data from National Inpatient Sample, HCUP/AHRQ

Deyo, Nachemson, Mirza NEJM 2004

slide28

Inpatient Medicare Reimbursement

Weinstein, Lurie et al Spine 2006

slide29

Inpatient Medicare Reimbursement

19922003

Rate of Lumbar Fusion 30 per 100k 110 per 100k

Spending for Lumbar Fusion $75 million $482 million

Percent Spending for Fusion 14% 47%

Weinstein, Lurie et al Spine 2006

slide36

Office Visits for Back Pain

Deyo, Mirza, Martin Spine 2006

slide37

National Health Interview Survey 2002

Deyo, Mirza, Martin Spine 2006

slide38

National Health Interview Survey 2002

Deyo, Mirza, Martin Spine 2006

slide39

National Health Interview Survey 2002

Deyo, Mirza, Martin Spine 2006

slide40

US Prevalence of Back Pain

Deyo, Mirza, Martin Spine 2006

slide41

US Prevalence of Back Pain

Deyo, Mirza, Martin Spine 2006

favorable results in industry sponsored research
Favorable Results in Industry-Sponsored Research

SponsorOdds Ratio95% CI

Sponsor of study 3.6 2.6 to 4.9

For-profit organizations 5.3 2.0 to 14.4

Manufacturer of drugs 8.0 1.1 to 53.2

Spinal device manufacturer 3.3 2.4 to 4.5

Jacobs, Galante, Mirza, Zdeblick JBJS 2006

slide45

Favorable Results

Field Industry-fundedIndependent

Spine 73% 44%

Hip 93% 37%

Knee 75% 20%

slide46

“Surgeons have often touted procedures that ultimately proved to be disappointing.”

April 8, 2002

slide47

April 8, 2002

“Trisha Bryant assumed that the procedures her surgeon recommended were necessary and had been validated by research. I, too, made that assumption….If Trisha had explored the medical literature, however, she would have discovered that every aspect of her case– the interpretation of the MRI scan, the diagnosis of spinal instability, the rationale for fusing vertebrae, the impending discography– was controversial…”

slide48

April 8, 2002

“… within the surgical profession there’s a curious gap between rhetoric and reality.”

“Spinal instability is routinely given as a diagnosis to these patients with chronic lower-back pain. It is a term used to justify an operation. And it is a great diagnosis, because it can’t be directly disproved.”

Surgeon who performs two to three spinal fusions a week.

“Each approach to diagnosis and treatment is essentially a franchise, and there are too many franchises battling.”

Seth Waldeman

Pain Medicine, HSS

slide49

Conclusions

  • Biological basis for “discogenic back pain” is not known.
  • Rates of lumbar fusion for chronic back pain have increased without increase in prevalence of back pain.
  • Investigator-sponsor financial conflicts are common.
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